The trial is a randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of Epliga for the adjunctive treatment of refractory partial onset seizures in patients with epilepsy.
Epliga is a novel controlled release once-per-day dosage form of oxcarbazepine that is designed to improve compliance and reduce adverse events. Supernus has previously completed a proof-of-concept study where Epliga showed significant improvement in key adverse events compared to the reference product Trileptal.
Jack Khattar, president and CEO of Supernus, said: “Initiating our Phase III trial for Epliga is a major milestone for Supernus and an important step toward addressing a significant unmet need in the treatment of epilepsy. We are excited about Epliga and its potential for offering epilepsy patients an effective anti-convulsant therapy with much-needed lower side effects and the convenience of once-per-day dosing.”